MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed and the cause appeared to be related to use of the device.One 8cm x 20g powerglide catheter was returned for investigation.Blood residue was visible within the catheter.The catheter was kinked just distal to the pink strain relief sleeve.A microscopic examination of the kink revealed a 2mm longitudinal split in the catheter just distal to the pink oversleeve.The split coincided with the terminus of the crease in the kinked catheter.A functional test revealed a spraying leak where the tubing was split just distal to the pink strain relief sleeve.The remainder of the catheter was occluded with a dry red colored residue.The catheter may have split open from a combination of overpressurization and fatigue.Both the residue and the kink may have created an occlusion within the device.It was reported that the ct tech had problems getting contrast in.The product ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ the ifu also warns, ¿failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ another warning in the ifu states, ¿power injector machine pressure limiting feature may not prevent overpressurization of an occluded catheter, which may lead to catheter failure.¿ a lot history review (lhr) of rebw1706 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that the patient went to ct for ct with contrast.It was stated ct tech attempted to give contrast, had problem getting contrast in, attempted again, then nurse noticed blood dripping from iv.The dressing removed and it was reported that blood was dripping from catheter near insertion site.

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7383938
• Report Number: 3006260740-2018-00562
• Device Sequence Number: 19137822
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REBW1706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72